drugset / Trial / NCT02246998
Renal Effect of Stribild or Other Tenofovir DF-containing Regimens Compared to Ritonavir-boosted Atazanavir Plus Abacavir/Lamivudine in Antiretroviral Treatment-naive HIV-1 Infected Adults
RandomizedParallel-groupOpen-labelTreatment
Summary
The primary objective of this study is to assess glomerular function before and during administration of stribild (STB; elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (E/C/F/TDF)) or a regimen containing TDF without cobicistat (COBI) as ritonavir (RTV)-boosted atazanavir (ATV/r) plus truvada (TVD; FTC/TDF) or atripla (ATR; efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF)) compared to a regimen containing neither TDF nor COBI as ATV/r plus abacavir/lamivudine (ABC/3TC) via determination of actual glomerular filtration rate (aGFR) using iohexol (a probe GFR marker) plasma clearance and estimated (calculated) glomerular filtration rate (eGFR).
Timeline
- Start
- 2014-12-15
- Primary completion
- 2016-01-20
- Completion
- 2016-02-17
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Abacavir | Other / unclassified | 600 mg | Oral |
| Subject | Atazanavir | Other / unclassified | 300 mg | Oral |
| Subject | Cobicistat | Small molecule | 150 mg | Oral |
| Subject | Efavirenz | Other / unclassified | 600 mg | Oral |
| Subject | Lamivudine | Other / unclassified | 300 mg | Oral |
| Subject | Ritonavir | Other / unclassified | 100 mg | Oral |
| Subject | Tenofovir disoproxil fumarate | Small molecule | 300 mg | Oral |
| Subject | elvitegravir | Small molecule | 150 mg | Oral |
| Subject | emtricitabine | Other / unclassified | 200 mg | Oral |